Intervention to Improve HCV Treatment Uptake and Adherence in HIV/HCV Coinfection

描述(由申请人提供)：迫切需要采取干预措施，以增加艾滋病毒/丙型肝炎病毒共感染者对丙型肝炎病毒(丙型肝炎病毒)治疗的接受。终末期肝病现在是艾滋病毒阳性者死亡的主要原因，主要是由于未经治疗的慢性丙型肝炎病毒感染，尽管丙型肝炎病毒治疗的有效性取得了重大进展，但丙型肝炎病毒治疗的接受率仍然很低。这项研究将开发一种干预措施，解决患者层面(信息、动机和行为技能)对HIV合并感染患者接受丙型肝炎治疗的障碍，并测试其可行性、可接受性和初步疗效。在形成性研究的基础上，我们开发了“丙型肝炎治疗的心理社会准备评估和准备(PREP-C)”。PREP-C是一种结构化的基于网络的访谈，它评估客户开始接受丙型肝炎治疗的心理社会准备情况，并确定需要干预以改善治疗准备情况的功能领域。PREP-C已在近100名患者中进行了试点，并于2012年推出了面向医疗保健提供者的远程医疗资源(www.prepc.org)。在这项研究中，我们将开发和测试一种综合评估-行为干预，以增加HIV合并感染患者的丙型肝炎治疗启动率。我们的具体目标是：(1)正式调整基于PREP-C评估的现有行为医学干预措施，以针对在医学上有资格接受丙型肝炎病毒治疗的艾滋病毒/丙型肝炎合并感染患者启动丙型肝炎治疗的个人障碍(信息、动机和行为技能)，对15名艾滋病毒/丙型肝炎合并感染患者进行试点测试和改进量身定制的干预措施，并最终完成干预手册。(2)对60名医学上有资格接受丙型肝炎病毒治疗的艾滋病毒/丙型肝炎病毒混合感染患者进行试点随机临床试验，比较护士提供的PREP-C干预(n=30)和注意力控制(n=30)，以评估患者接受度、患者满意度、登记和保留以及初步疗效(在随机和持续治疗的6个月内开始治疗丙型肝炎病毒，以及在开始治疗的人坚持治疗的前12周)。我们假设，PREP-C干预将增加动机、信息和自我效能，导致在PREP-C干预组中更高的丙型肝炎治疗启动率、持久性和依从性。这项先锋研究的结果将为R01应用中更大、更严格的评估提供设计参数，如果结果有希望的话。PREP-C基于网络的评估和干预一揽子计划旨在具有可伸缩性，并可通过现场直播的PrepC.org网站传播。这项拟议的研究具有创新性，因为它寻求开发第一个基于网络的干预措施，供卫生保健提供者使用，以增加艾滋病毒/丙型肝炎联合感染者的丙型肝炎治疗启动。这项研究可以对公共卫生产生重大影响，为卫生保健提供者提供必要的结构化资源，以提高艾滋病毒/丙型肝炎合并感染者开始接受丙型肝炎治疗的比率，从而降低因终末期肝病而导致的死亡率。

DESCRIPTION (provided by applicant): There is an urgent need for interventions to increase hepatitis C virus (HCV) treatment uptake among HIV/HCV-co-infected persons. End-stage liver disease is now a leading cause of death among HIV-positive persons, largely due to untreated chronic HCV infection, and rates of HCV treatment uptake remain low despite significant advances in the effectiveness of HCV treatment. This study will develop an intervention addressing patient-level barriers (Information, Motivation, and Behavioral Skills) to HCV treatment uptake in HIV-co-infected patients and test its feasibility, acceptability, and preliminay efficacy. Based on formative research, we have developed the "Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C)". PREP-C is a structured web-based interview that provides an assessment of a client's psychosocial readiness to begin HCV treatment and identifies domains of functioning which require intervention to improve treatment readiness. PREP-C has been piloted in almost 100 patients and a telemedicine resource for health care providers was launched in 2012 (www.prepC.org). In this study, we will develop and test an integrated assessment-behavioral intervention to increase HCV treatment initiation among HIV-co-infected patients. Our specific aims are: (1) To formally adapt existing behavioral medicine interventions based on PREP-C assessment to target individual barriers (Information, Motivation, and Behavior Skills) to HCV treatment initiation in HIV/HCV-co-infected patients who are medically eligible for HCV treatment, pilot test and refine the tailored intervention in 15 HIV/HCV-co-infected patients, and finalize the intervention manual. (2) To conduct a pilot randomized clinical trial with 60 HIV/HCV-co-infected patients who are medically eligible for HCV treatment, comparing the nurse-delivered PREP-C intervention (n=30) with attention control (n=30) in order to evaluate patient acceptance, patient satisfaction, enrollment and retention, as well as preliminary efficacy (initiation of HCV treatment within 6 months of randomization and persistence and adherence to the first 12 weeks of treatment in those who do initiate treatment). We hypothesize that the PREP-C intervention will increase Motivation, Information, and Self-Efficacy leading to higher rates of HCV treatment initiation, persistence and adherence in the PREP-C intervention arm. Findings from this vanguard study will inform the design parameters of a larger, more rigorous evaluation in an R01 application, if results are promising. The PREP-C web-based assessment and intervention package is designed to be scalable and can be disseminated through the live PrepC.org web site. The proposed study is innovative in that it seeks to develop the first web-based intervention for health care providers t use to increase HCV treatment initiation in HIV/HCV-co-infected persons. The study can have a major public health impact by providing needed structured resources for health care providers to increase rates of HCV treatment initiation in HIV/HCV-co- infected persons, thereby reducing mortality due to end-stage liver disease.